A Study of Vantictumab (OMP-18R5) in Combination With Paclitaxel in Locally Recurrent or Metastatic Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2017-12-31

Brief Summary

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This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and PK of vantictumab when combined with paclitaxel.

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Detailed Description

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Once the maximum tolerated dose (MTD) or maximum administered dose (MAD) has been determined, up to 10 patients may be enrolled in the cohort-expansion phase to better characterize the safety, tolerability and PK of vantictumab combined with paclitaxel. Up to approximately 34 patients may be enrolled into the study.

Conditions

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Metastatic Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vantictumab combined with paclitaxel

Drug: vantictumab combined with paclitaxel - administered intravenously

Group Type EXPERIMENTAL

Vantictumab combined with paclitaxel

Intervention Type DRUG

Vantictumab combined with paclitaxel will be administered IV.

Interventions

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Vantictumab combined with paclitaxel

Vantictumab combined with paclitaxel will be administered IV.

Intervention Type DRUG

Other Intervention Names

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(OMP-18R5)

Eligibility Criteria

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Inclusion Criteria

* Signed Informed Consent Form
* Age ≥18 years
* Histologically documented adenocarcinoma of the breast with locally recurrent or metastatic disease

o Patients with breast cancer overexpressing HER2 are not eligible.
* Availability of tumor tissue, either archival FFPE or obtained at study entry through fresh biopsy
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* All acute treatment-related toxicity from prior therapy must have resolved to Grade ≤ 1 prior to study entry
* Adequate hematologic and end-organ function
* Evaluable or measurable disease per RECIST v1.1
* For women of childbearing potential, agreement to use two effective forms of contraception

Exclusion Criteria

* Known significant dose delays during prior treatment with a taxane due to drug-related toxicities
* Prior treatment with more than two regimens of systemic cytotoxic chemotherapy for locally recurrent or metastatic disease
* Treatment with any anti-cancer therapy within 3 weeks prior to initiation of study treatment

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No